Escolar Documentos
Profissional Documentos
Cultura Documentos
www.cliantha.in
History
2004
FoundedBAResearchIndiaLimited,nowrenamedasClianthaResearchLimited Inauguratedwith122bedsand4LC/MS/MS,CentralReferenceLabaccreditedbyCAP InauguratedanewfacilityatVadodaracity(2hourdrivefromAhmedabad) with200bedsandCAPaccreditedPathLab Bioanalyticallabupgradedto13LC/MS/MS IntroducedTransdermalclinicalstudies IntroducedanewfacilityinAhmedabadwithcapacityof100beds
2007
2009
2010
2011
2012
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2012ClianthaResearchLimited
Winnipeg
CANADA
MexicoCity St.Petersburg Ahmedabad
INDIA
Vadodara
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SubmissionsandSponsors
2012ClianthaResearchLimited
Accreditations&Inspections
GovernmentOfIndia Facilitiesinspected&approved byDrugsControllerGeneralof India RecentinspectioninOct2011 InspectedfacilityinNov2006
RecentinspectioninJune2012
InspectedinFeb2011
InspectedandcertifiedCliantha facilityinMexicoCityinApril2012
InspectedfacilityinJan2009
InspectedfacilityinApril2011
InspectionofDiagnosticlabin Aug2011
RecentinspectionofDiagnosticLabin July,2012
LocationsregisteredinSeptember,2012
2012ClianthaResearchLimited
RegulatoryInspectionsHistory India
ClianthaResearchhasbeensuccessfullyinspectedbyfollowingregulatoryagencies:
Date
Nov0611,2006 May1417,2007 Sep2021,2007 Sep1519,2008 Jan1213,2009 Jun1723,2010 Oct1820,2010 Oct1822,2010 Oct2527,2010 Feb910,2011 April1112,2011 April1315,2011 Oct37,2011 Jun1922,2012
Inspection
AhmedabadHQbyANSM(GCP&GLP) AhmedabadHQbyUSFDA(GCP) AhmedabadHQbyUSFDA(GCP,GLP&Stats) VadodarabyUSFDA(GCP) AhmedabadHQbyMCC(GCP,GLP&Stats) AhmedabadHQbyUSFDA(GLP&Stats) AhmedabadHQbyWHO(GCP,GLP&Stats) AhmedabadSigmabyUSFDA(GCP) AhmedabadHQbyUSFDA(GCP) VadodarabyAGES(GCP) VadodarabyAEMPS(GCP) AhmedabadHQbyAEMPS(GLP&Stats) VadodarabyUSFDA(GCP) AhmedabadHQandSigmabyWHO(GCP,GLP&Stats)
AllthethreelocationsofClianthaResearchLimitedareinspected&approvedbyDrugControllerGeneralofIndia(DCGI) 6
2012ClianthaResearchLimited
RegulatoryInspectionsHistory India
DiagnosticLab:
Date
Sep,2007 Sep,2008 Sep,2009 Sep,2010 Aug,2011 Aug,2011 July,2012
Inspection
ClianthaHQbyCAP ClianthaVadodarabyCAP ClianthaSigmabyCAP ClianthaVadodarabyCAP ClianthaSigmabyCAP ClianthaVadodarabyCAP ClianthaSigmabyANVISA
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2012ClianthaResearchLimited
RegulatoryInspectionsHistory Mexico
ClianthafacilityinMexicoCityhasbeeninspectedandcertifiedbyCofepris inApril2012andisnowfullyoperational
2012ClianthaResearchLimited
OurServices
ClianthaTrials
BA/BEStudies
Dermatology
Personal Healthcare
Biometrics
Central ReferenceLab
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2012ClianthaResearchLimited
ClianthaTrials
Infrastructuresetuptoconductglobal PhaseIIVtrials 1500+GCPtrainedvalidatedqualityinvestigator sitesinUSA,EUandIndia Therapeuticareas:Oncology/Hematology, Dermatology,Psychiatry,Cardiology, Diabetology,Ophthalmologyand Gastroenterology Combinedteamexperienceofmorethan 50yearsinclinicaltrials Formoredetailslogonto: www.clianthatrials.com
2012ClianthaResearchLimited
Expertisein:
Globalfeasibilitystudies Projectmanagement Sitemanagementandrisk basedmonitoring Regulatoryaffairs Supplymanagement Centrallabservices
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BA/BEStudies
Conductedover1500studies 9clinicalunits,400beds,12ICUbedsand 20doctors CentralLabaccreditedbyCAP 55,000healthysubjectsdatabase Infrastructureincludesfreezers,cardiac monitors,securedpharmacy,controlled archives,andpowerbackup
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2012ClianthaResearchLimited
Bioanalytical
LabsinIndiaandMexicoCity Over180analyticalmethodsinbiological fluids 21LC/MS/MS(API3000,4000,5500) ICPOESforelementalanalysis Over1.5millionsamplesanalyzed
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2012ClianthaResearchLimited
Dermatology
ClianthaResearchacquiredHillTopResearch, whichspecializesinmanagingPhaseIIV clinicaltrialswithfocusonDermatology Opportunitytoexecutestudiesinmultiple locationswithmultipleclimaticconditionsin N.Americaand/orIndia EstablishedGlobalInterscorervariability
Expertisein:
Transdermal/Topical Bioequivalence ContactSensitization HumanRepeatInsultPatch Test(HRIPT) CumulativeIrritation(14 and21daystudies) Wearstudies SkinBlanching (Vasoconstrictionstudies)
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2012ClianthaResearchLimited
PersonalHealthcare
HillTopResearch,withover65yearsexperience inPersonalHealthcareindustry Twolocationswithdifferentclimaticconditions andpatientpool SafetystudiesforOTC,cosmeticandpersonal healthcareproducts
Expertisein:
Phototoxicity Photoallergy Comedogencity Skincare antiaging, moisturizers,skinofcolor Antiperspirantsand deodorants PersonalHygieneproducts Babycareproducts Femininecareproducts Cosmeticproducts
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2012ClianthaResearchLimited
Biometrics
Fullservice CDM,PharmacokineticsandStatistics InfrastructurebasedinIndia eCRFandpaperCRF SASPheedIT Libraries MedDRA,WHODD WinNonlin Pharmacokineticanalysis SAS Statisticalanalysis Reports FDA,ICHE3,TPD,TGAformats
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2012ClianthaResearchLimited
CentralReferenceLab
CAPaccreditedlabwithstateoftheartfacilities formulticentricClinicalTrials Completerangeofspecializedtestswitha test menucoveringHematology,Coagulation, Clinicalchemistry,Immunology,Serology,Clinical Pathology,FlowCytometry CombinesinnovativeR&Dcapabilitiesfor developingandvalidating ligandbindingassays formacromoleculesforPKandimmunogenicity studies CapabilitiestodevelopandvalidateanAssayto meetspecificneedsofaprotocol
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QualityAssurance(QA)
QAteamindependentlymonitorsallactivitiesensuringcompliancetoProtocol, SOPs,GCP,GLPandotherregulations:
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Projectflow
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TypicalTimelinechart
Day 07 814 1521 2228 2935 3642 4349 5056
(Assumptions: No. of subject: 36, No. of periods: 2,Washout period: 7 days; Delivery in < 120 days)
5763
Week
Project Confirmation Protocol finalization EC&BENOC/T License MD/MV (ifapplicable)
W1
W2
W3
W4
W5
W6
W7
W8
W9
Day
64-70
71-77
78-84
85-91
92-98
99-105
106 -113
114-120
Week
IPTransfer ClinicalPhase completion Bioanalysis PK/Statistics Draftreport Finalreport
W10
W11
W12
W13
W14
W15
W16
W17
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Casestudy
FlawlessfastestANDA FirsttoFilesubmission:
CompletedUSFDAbiosubmission studywithinaweek Meticulouscoordinationbetween therespectiveteamsenabledto accomplishperfectstudyanddeliver thedatawithoutcompromisingany ethicalstandards Clinicstarts Clinicends Bioanalysis starts Bioanalysis ends Milestones FastingBE Study(n=36) 04Apr2012 08Apr2012 08Apr2012 10Apr2012 FedBEstudy (n=36) 05Apr2012 09Apr2012 09Apr2012 10Apr2012 10Apr2012
Finalreport 10Apr2012
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Team
VijayPatel
ExecutiveDirector 21yearsManagementexperience
RahulNijhawan
AssociateDirector,GlobalProjectManagement 12yearsResearchexperience
NaveenSharma
ChiefOperatingOfficer 17yearsResearchexperience
ArpanaPrasad
AssociateDirector,Bioanalyticallab 15yearsBioanalyticalexperience
Dr.RobertA.Harper
President 25yearsDermatologyexperience
AnshulDogra
AssociateDirector,Bioanalyticallab 12yearsBioanalyticalexperience
Dr.CharuGautam
Director,GlobalClinicalOperations 13yearsClinicalexperience
Dr.ShaifaliGupta
Head,CentralReferencelab 11yearsPathologyexperience
AnitaKaul
VicePresident,GlobalQualityAssurance 20yearsQAexperience
Dr.SimranSethi
GeneralManager,MedicalAffairs 13yearsofResearchexperience
HiteshChauhan
AssociateDirector,Biometrics 12yearsofStatistics&CDMexperience
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2012ClianthaResearchLimited
OurAssets
Clianthateam
700 andgrowingincluding20doctors Combinedexperienceofover50yearsatleadingpharmacosandCROs
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ThankYou
www.cliantha.in
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2012ClianthaResearchLimited